Pausing Stem Cell Research…Again

When President Obama signed an executive order last March loosening the restrictions on embryonic stem cell research, it seemed like the shackles were finally off for good. The new policy rolled back the “Bush compromise” forbidding federal funding of research on any newly created stem cell lines, leaving only 21 lines (at most) eligible for the grants that support the vast majority of laboratory research in the United States. After Obama’s decision, the floodgates didn’t exactly open, but embryonic stem cell research received a significant boost, with more than 300 projects receiving nearly $150 million in National Institutes of Health funding. In the 18 months since the executive order was signed, the number of eligible stem cell lines has expanded from 21 to 75.

But just as American stem cell research was starting to enjoy the regained momentum, an emergency brake was pulled this week by a federal judge in the District of Columbia. Judge Royce Lamberth issued a temporary injunction Monday that found Obama’s executive order in violation of the “Dickey-Wicker amendment,” a ban on giving federal money to research involving the destruction of human embryos that has been attached by Congress to each year’s federal spending bill since 1996. Lamberth interpreted research conducted on embryonic stem cell lines, even long after the original destruction of an embryo to create those lines, as being illegal under the amendment. Despite previous rulings that differentiated between research on an embryo and research using stem cells derived from an embryo, Lambeth ruled that (at least temporarily) NIH funding of embryonic stem cell (ESC) research must stop.

“ESC research is clearly research in which an embryo is destroyed,” Lamberth wrote in the injunction. “To conduct ESC research, ESCs must be derived from an embryo. The process of deriving ESCs from an embryo results in the destruction of the embryo. Thus, ESC research necessarily depends upon the destruction of a human embryo.”

The reaction from the scientific community, as you might guess, has been less than celebratory.

“This decision has the potential to do serious damage to one of the most promising areas of biomedical research, just at the time when we were really gaining momentum,” said Dr. Francis S. Collins, director of the National Institutes of Health. The ruling, he added, “just pours sand into that engine of discovery.” (New York Times, 8/25)

“‘I have had to tell everyone in my lab that when they feed their cells tomorrow morning, they better use media that has not been funded by the federal government,’ said Dr. George Q. Daley, director of the stem cell transplantation program at Children’s Hospital Boston, referring to food given cells. ‘This ruling means an immediate disruption of dozens of labs doing this work since the Obama Administration made its order.” (New York Times, 8/24)

“Basically, they are saying that all ESC research is a part of a broader system of research that includes the initial destruction of embryos. Which would be kind of like saying that all research into nuclear power stems from the Manhattan Project,” he says. (Hank Greely, director of the Center for Law and the Biosciences at Stanford University, Nature News, 8/24)

The ruling hit close to home too, as our own John Cunningham, professor of pediatric and director of hematopoietic stem cell transplantation, told Chicago Public Radio yesterday. Cunningham, who hopes to use embryonic stem cells to study leukemia and other blood diseases, expressed his frustration at having to once again put all such projects on hold due to politics and legal rulings.

“As we go through this process of stopping and going and stopping and going, it really retards our ability to make decisions based on science,” Cunningham told WBEZ.

Even more troubling is the possibility that Lamberth’s ruling could create a research-strangling precedent that extends far beyond stem cells. As William Saletan of Slate sees it, the ruling’s definition of research would render even Bush’s decision illegal, not to mention many other areas of health science:

In fact, Lamberth’s definition of “research”-incorporating all prior steps on which present studies depend-would jeopardize lots of other work. Current research on hypothermia, asthma, schizophrenia, hepatitis, radiation exposure, gene therapy, and sexually transmitted diseases relies, to varying degrees, on prior experiments that were deemed illegal or unethical. Are scientists who work in these fields responsible for the sins of their predecessors? Should we declare their work “research in which” Jews, blacks, children, and others are victimized? Do we seriously think that Congress, in using the word “research,” intended such retroactive complicity?

Another worrisome precedent lies in the argument of two controversial plaintiffs on the case, scientists who use adult stem cells for research and who claimed the loosening of restrictions hurt their ability to receive federal funding. As a Nature editorial explained last month, recognizing that complaint as valid could completely rewrite the way federal funding is handed out for research, taking decisions about what projects should be funded out of the traditional peer review process. As the Department of Justice plans to immediately appeal Lamberth’s ruling, the entire scientific community – not just the stem cell researchers – will be intently focused on the proceedings.